Research question:

The objective of this investigation is to assess the benefit of independent use of an active motion device, also called controlled active motion (CAM) device, in adult patients with conservatively or surgically treated ankle fracture in comparison with standard care without the independent use of an active motion device with regard to patient-relevant outcomes.

Conclusion:

For the independent use of CAM devices following surgical therapy, 1 study was found, comparing postoperative treatment with CAM devices versus postoperative treatment without CAM device. The study population was small, and the study had methodological flaws. However, for the outcomes of foot pain, foot function, other complaints (Visual Analogue Scale Foot and Ankle, VAS FA), full weight-bearing, regaining fitness to work, and health-related quality of life (physical component summary [Short Form (SF)-12]), a hint of benefit of additional mobilization via the independent use of a CAM device in comparison with standard care without CAM device was consistently found.

With regard to the range of motion (ROM) outcomes, health-related quality of life (mental component summary [SF-12]), adverse events, and revision surgery, there was no hint of benefit or harm of the independent use of a CAM device in comparison with standard treatment without CAM device.

No data were available for the outcomes of activities of daily living, dependence on help from others, or participation in professional and social life.

Overall, for independent use by adult patients following a surgically treated ankle fracture, a hint of benefit of additional mobilization via CAM device was found in comparison with standard treatment without CAM device.

No studies were found on additional mobilization through the independent use of a CAM device in patients with conservatively treated ankle fracture. For the subpopulation of conservatively treated adult patients who are allowed partial loading, the results are deemed transferable, and a hint of benefit of a CAM device is found in comparison with standard treatment without CAM device.

Due to the weak evidence on which the benefit assessment is based, conducting a confirmatory randomized controlled trial (RCT) should be considered in the present indication. This RCT should include both adult patients with surgically treated ankle fracture and those with conservatively treated ankle fracture which can be (at least) partially loaded.

For adult patients with conservatively treated ankle fracture who are not allowed partial loading of the joint, the independent use of a CAM device seems inadequately indicated and difficult to implement. Hence, the result cannot be transferred to this subpopulation. For these patients, no hint of benefit nor the potential of a required treatment alternative was found.

Publisher

Institute for Quality and Efficiency in Health Care

Topic

Independent use of an active controlled motion device in the treatment of ankle fractures

Commissioning agency

Federal Joint Committee

Commission awarded on

15 October 2020

Internal Commission No.

N20-05

Address of publisher

This report was prepared in collaboration with external experts.

The responsibility for the contents of the report lies solely with IQWiG.

According to §139b (3) No. 2 of Social Code Book (SGB) V, Statutory Health Insurance, external experts who are involved in the Institute’s research commissions must disclose “all connections to interest groups and contract organizations, particularly in the pharmaceutical and medical devices industries, including details on the type and amount of any remuneration received”. The Institute received the completed Form for disclosure of potential conflicts of interest from each external expert. The information provided was reviewed by a Committee of the Institute specifically established to assess conflicts of interests. The information on conflicts of interest provided by the external experts and external reviewers is presented in Chapter A9 of the full report. No conflicts of interest were detected that could endanger professional independence with regard to the work on the present commission.

External expert

• Henning Kunter, Protestant Hospital Kalk, Cologne, Germany

IQWiG thanks the external expert for his collaboration in the project.

IQWiG employees

• Sandra Molnar
• Daniel Fleer
• Corinna Kiefer
• Marco Knelangen
• Fabian Lotz
• Andrea Steinzen